US Priority Review for B-MS' Opdivo in Lung Cancer

Monday, March 2, 2015

Source: Pharma Times

The US Food and Drug Administration has agreed to review Bristol-Myers Squibb’s PD-1 inhibitor Opdivo (nivolumab) as a treatment for advanced squamous non-small cell lung cancer (NSCLC) after prior therapy.

The regulator also said it would undertake a priority review of the application, and that the Prescription Drug User Fee Act goal date for a decision is June 22, 2015.

The submission is based on data from the Phase II trial CheckMate-063, in which the estimated one-year survival rate was found to be 41% in patients given the drug.

Opdivo has a good shot at becoming the first immunotherapy cleared for the treatment of advanced squamous NSCLC. But Merck & Co's rival Keytruda (pembrolizumab) could be hot on its heels - the company recently said it would be fiing its immunotherapy in the first half of this year.

 

 

Read more at: http://www.pharmatimes.com/Article/15-03-01/US_priority_review_for_B-MS_Opdivo_in_lung_cancer.aspx#ixzz3TGaew4En 

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Read more at: http://www.pharmatimes.com/Article/15-03-01/US_priority_review_for_B-MS_Opdivo_in_lung_cancer.aspx#ixzz3TGabSWGo 

Follow us: @PharmaTimes on Twitter

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